PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Envelope Label Collection Bag Label Plasma Bag Label Transfer Bag Label

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS There are no known potential adverse reactions associated specifically with the Leukotrap WB System with CPDA-1.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE Indicated for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction. Platelet concentrates are not intended to be made with this product.

SPL UNCLASSIFIED SECTION.


V. PROCESSING INSTRUCTIONS 1. Load whole blood and remaining bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup. 2. Centrifuge at conditions designed to produce desired components. 3. Carefully remove the unit from the centrifuge and place the collection bag in the plasma expressor. 4. Clamp tubing to extra satellite bag(s), if present. 5. Gently apply expressor pressure. 6. Open snap-open closure on collection bag and express plasma. 7. After plasma is expressed, clamp tubing between satellite bag(s) whole blood bag and release expressor pressure. 8. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.* Note: If pre-filtration quality control is to be performed, leave an adequate length (~10 inches) of QC tubing containing anticoagulated blood attached to the collection bag. 9. Gently mix packed red cells. 10. Store CPDA-1 preserved red blood cells at 16 C for up to 35 days and use as indicated.

HOW SUPPLIED SECTION.


HOW SUPPLIED Each shipping case contains 6 foil envelopes. Within each foil envelope resides 3 units of the collection system. Each unit consists of a collection bag with 70 ml of CPDA-1 solution and two empty bags.

DESCRIPTION SECTION.


DESCRIPTION CPDA-1 Blood Collection Set, Quadruple Bag with WBF2 Filter and Sampling System Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx only. This product is free of natural rubber latex.

PRECAUTIONS SECTION.


GENERALPRECAUTIONS Use Aseptic Technique. Use only if solution is clear. Store CPDA-1 preserved red blood cells at 16 C for up to 35 days and use as indicated. * During processing, always observe the following precautions: 1. Sealing should be done in a manner that avoids fluid splatter. 2. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.

REFERENCES SECTION.


REFERENCES HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation. DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia. Manufactured for: Haemonetics Corporation 400 Wood Road Braintree, MA 02184, USA By: Haemonetics Manufacturing Inc. 1630 Industrial Park Street Covina, CA 91722, USA www.haemonetics.com 800-537-2802

WARNINGS SECTION.


WARNINGS Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours.